Comparing Outcomes of Hemodialysis Patients Using Medium Cut-Off Dialyzers Versus High-Flux Hemodialysis or Hemodiafiltration

What this Trial Is About

Researchers are evaluating clinical and biochemical outcomes in patients with end-stage kidney disease ESKD undergoing maintenance hemodialysis. This observational study compares the use of medium cut-off MCO dialyzers Theranova with high-flux hemodialysis HF-HD and hemodiafiltration HDF. The goal is to determine whether MCO dialyzers are linked to better survival and health outcomes compared to HF-HD, and whether they perform at least as well as HDF. The study is motivated by high mortality rates among dialysis patients and variations in treatment outcomes across regions. The study uses real-world data from non-DOPPS centers using Theranova dialyzers and compares this to external control data from the DOPPS cohort, which includes patients treated with HF-HD and HDF. This retrospective design involves collecting data on patients demographics, comorbidities, dialysis prescriptions, and laboratory results. Participants are adults receiving in-center maintenance hemodialysis. Data collection spans from March to June 2026 and includes approximately 500 to 1000 Theranova patients alongside control groups. During the study, researchers will review all-cause mortality over three years as the primary outcome. Secondary outcomes include cardiovascular events, infections, hospitalizations, and biochemical measures related to anemia, mineral balance, and inflammation. Patient data privacy is ensured through pseudonymization techniques. Statistical methods will adjust for differences in patient characteristics to fairly compare outcomes across groups. This study aims to provide meaningful real-world evidence about the effectiveness of MCO dialyzers to inform clinical practice and future research.

Comparisons Of Biochemical And Clinical Outcomes Of Hemodialysis Patients Treated With Middle Cut-Off Dialyzers Versus High-Flux Hemodialysis Or Hemodiafiltration